Tell Us Your Ideas: How Should FDA Inform the Public About Inspection Results

FDA conducts many inspections. A completed Form FDA-483 lists observations made during an inspection of a firm. Responding to Freedom of Information Act (FOIA) requests for these reports of inspectional observations, however, often takes a lot of time because of the need to redact non-public information, such as trade secret and confidential commercial information, from the inspection report.

FDA seeks input on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly. Disclosure of full inspectional observation reports would still require the same review for non-public information as it does now.

Does this sound like a good idea? If so, what would be key points to be included in the summary page? What, if any, other ways can the agency use to provide results of inspections to the public quickly?

We look forward to your feedback.

Transparency Task Force

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Redesigning inspection reports to separate out a summary or key findings to be made available to the public online would be an excellent idea.
Basic information such as origin, any “objectionable conditions” or general negative observations, as well as other basic/general information would be good to include.

I think this is a good idea. FOIA requests often take too long to fill because of the predicament mentioned. Often, useful information takes far too long to be made available to the public because of the bureaucratic nature of FOIA.
If the FDA could provide a brief summary and a key finding report (similar to those done by the GAO), the public could receive useful information quickly. Those seeking more information could go through the process as is laid out in FOIA.
Transparency in government is important. The Internet has made Americans more connected than ever before. It is my opinion that the more collaborative our government can be, the better.
The American people would definitely benefit from having easier access to the findings of agencies like the FDA. This is information the Americans can use immediately, so the sooner it’s made available, the better.

I am writing to you about the conduct of FDA’s establishment inspections and EIR’s for clinical trials. For example Establishment Inspection Report (EIR), FEI 2082851. The inspection was conducted by an ORA field investigator, listed currently in the FDA directory as a Tissue Residue Monitor. One would ask why a Tissue Residue Monitor was monitoring a high priority Bioresearch CDER inspection of a complex clinical trial. The report documents violations of the Code of Federal Regs, but the investigator did not receive a warning. This is especially troubling because a patient died while participating in the clinical trial. The inspection report did not address patient safety and left out important details, for example, why the patient was called a clinical cure at the end of the study, when the patient was in fact seriously ill. The ORA investigator followed compliance 7348.811, for clinical investigators. This guidance requires the investigator to comment on (in detail) protocol deviations, patient recruitment,IC, staff reponsibilities. If the FDA do not follow their own directives, the FOIA issue is mute. As in the case of EIR 2082851, the report is not of use to the public, other clinical sites or study patients, because the FDA did not provide any reason why they ignored the violations and decided to not issue a warning. it is necessary that the FDA conduct the inspection visits in a transparent way and document their findings in a transparent way so that the public know that the information in the EIR and or investigator notes, (even if the FDA withholds some info under the FOIA), is the most correct version of the inspecion findings.
With regards to EIR content- the drug under study was subject to an FDA safety alert a few months prior to the inspection. In addition the company had not reported 45 deaths to the FDA for a clinical trial testing the same drug under study for a different indication. Another trial was stopped immediately because of safety issues. The company cited database and study terminology issues as a reason for the under reporting of safety data. A research paper in CID states that patients who received inadequate medication and no medication for their specific infections died in this other trial. Despite this the ORA field investigator did not follow compliance program 7348.810 for sponsors and clinical trial oversight for this inspection.
Transparent standardized EIR classifications are essential, to assure the public that FDA puts patients safety first before the interests of other certain parties. A clear explanation of the operations of FDA inspections, training of field investigators/oversight would also be helpful. For example the field investigator signs off on the EIR, when it is clear the EIR has been reviewed by the Center, compliance and legal counsel.
FOIA takes too long. The requests are divided into simple and complex. complex immediately are put on the slow burner. An EIR is considered complex. Why? There is no guidance from the centers especially CDER as to what documents can be obtained under the FOIA. This is frustrating because it takes two years for the FDA to answer a request.
it seems that the FDA put as little info in the narrative section of the EIR and include the important info in the exhibit section. This allows the FDA to withhold information for no reason.
EIRs document patient safety and data integrity observations. Neither of these are trade secrets. The FDA should be trained better on the FOIA and not withold data for the sake of withholding data. This is frustrating for requestors especially following a two/three year wait for the info.

I agree that the transparency would be enhanced by making the observations available to the public. Because the observations are made by the inspector and may not be the official view of the agency, a separate agency report could be attached to the 483. This could be an overview report that does not contain non-public information.
This way the public would have the inspector’s opinion and the official agency review too.
The FDA is doing great work in this area of transparency and this will go a long way to show the impartiality of the agency to doing the best work for the people.

A one-page summary of findings that could be easily released is a very good idea. It would also be a good idea to renew FMD-145. This is the Field Management Directive that provided the inspected party with a copy of the EIR after the inspection was finalized. This policy was enacted so an EIR would be provided to the company or clinical investigator before it was released to the general public or, more commonly, business competitors. This is not happening in most of the districts and many people do not realize that they should be receiving a copy of their own inspection report. With transparency comes the responsibility to be fair to those who are inspected.

Since FDA-483 are evidence gathered for potential legal action, it may be a violation of a company’s legal rights to have a FDA-483 released without a legal review and opportunity for a response. Also, some FDA-483 contain annotations about findings corrected during an inspection, etc. What would be the purpose in releasing such information?
Occasionally, there have been errors in findings by FDA investigators that have to be corrected after the original FDA-483 is issued. What would be the opportunity to publicize the mistakes made by FDA in correcting these errors?
The due process accorded in the current process was placed there for a purpose. Has anyone explored why the current process is in place?
Certainly, the improvements to “protect the public health” are admirable, but what is the real purpose of this move?
If a Warning Letter may now be issued much more quickly to inform the public of the serious violations of the regulations and threats to public health, why would the minor violations of the regulations be helpful to protect the public health? Many of these FDA-483 cited violations are not threats to health, but in fact errors in paperwork.
The Warning Letter publication is the important information for the public and it might be diluted in the release of the thousands of inspections that are performed on an annual basis. The only beneficiary from FDA-483 release will probably be to the trial lawyers in more data mining for potential lawsuits.

I think this is a great idea.
So long as company/trade secrets are not jeapordized and boundaries respected, the public has a right to know the results of these inspections. After all, many decisions take such findings into consideration.

Redesigning and streamlining the reports to a single-page summary is the way to go. That would make it assessable quickly and easier to understand. Of course they have to designed in a way to keep trade secrets confidential.

I believe everything said was very reasonable.
However, what about this? what if you added a little content?
I mean, I don’t want to tell you how to run your blog, however what if you added a title to possibly grab a person’s attention?
I mean Tell Us Your Ideas: How Should FDA Inform the Public About Inspection
Results | FDA Transparency Blog is a little boring. You might peek at Yahoo’s front page and see how they write news titles to get viewers to open the links. You might add a video or a related pic or two to grab readers interested about everything’ve written.
Just my opinion, it would make your posts a little bit more interesting.

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